FDA Adverse Event
Malfunction
Summary report: N
ANSPACH® XMAX
MDR report key: 4153316
·
Received October 8, 2014
Report
- Report Number
- 1045834-2014-13267
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Report Date
- August 22, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- ERL
- PMA / PMN Number
- PK131053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE CAME IN FOR SERVICE AND WAS REPAIRED BY TECHNICIAN. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTED THE COUPLING WAS DEFECTIVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630653 | ANSPACH® XMAX | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |